Work

Efficacy and safety of a bio ‐absorbable antibiotic delivery in calcium sulphate granules for the treatment of osteomyelitis in patients with diabetic foot: A randomized, double blinded, controlled clinical study The BIG D‐ FOOT study

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: BACKGROUND: Diabetic foot osteomyelitis (DFO) is associated with a considerably high risk of incident major amputations, disability and mortality. To assess the effects of a local antibiotic delivery system on the incidence of post-surgical infective complications in patients with DFO. METHODS: This is a double-blind, placebo-controlled, parallel series, randomized controlled trial (RCT) aimed at verifying the efficacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (either with tobramycin or vancomycin) in patients with DFO treated with surgical procedures. The trial enrolled adult patients with diabetes and Texas 3 grade ulcers complicated by osteomyelitis and accompanied by deep tissues infection. The primary end-point was the percentage of infective complications (composite end-point of dehiscence, infection, DFO recurrence and new DFO in adjacent sites) at 12 weeks. RESULTS: The study was prematurely terminated after the completion of the first 20 cases, because of the significant superiority of the active treatment arm. After 12 weeks of treatment, five of 20 wounds (25%) achieved the primary composite end-point. All post-surgical infective complications occurred in the placebo group, with a significant between-group difference (unadjusted p = 0.010). No between-group differences in overall costs were observed. CONCLUSIONS: This is the first RCT in patients with DFO showing that the use of antibiotic-impregnated calcium-sulphate granules is economically sustainable and has the potential of improving the prognosis of DFO.

Source: Diabetes Obesity and Metabolism

DOI: 10.1111/dom.16254

Authors: Matteo Monami, Laura Bordoni, Benedetta Ragghianti, Giovanni Antonio Silverii, Edoardo Mannucci

Institutions: Azienda Ospedaliero-Universitaria Careggi, University of Florence

Language: English

Topic: Diabetic Foot Ulcer Assessment and Management

Subfield: Endocrinology, Diabetes and Metabolism

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $5,380